Seelos Therapeutics is preparing to conduct a global study investigating its intranasal racemic ketamine SLS-002, CEO Dr Raj Mehra told Clinical Trials Arena.
The Phase III trial will enrol adult patients with acute suicidal ideation and behaviour (ASIB) in major depressive disorder (MDD). The global trial will include patients from Asian countries, Western Europe and likely the US, with an expected 100 patients in each continent.
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Seelos has already engaged with Japan’s Pharmaceuticals and Medical Devices Agency (PDMA). As requested by the agency, Seelos conducted a Phase I trial in healthy Japanese and non-Asian subjects to evaluate the pharmacokinetic and pharmacodynamic profiles of SLS-002.
Seelos is planning to start this trial in 2024, but more detailed timelines will depend on the data readout from a Phase II registration-directed study in the US in Q3 2023.
Registrational Phase II trial in the US
Seelos is concluding its two-part Phase II trial (NCT04669665), which is being conducted in the US. The company expects to publish data from the second part, which is randomised, double-blind, and placebo-controlled, in Q3 2023.
Mehra explained that Seelos initially thought it would be a proof-of-concept study, but the US Food and Drug Agency (FDA) subsequently commented that it would be a registrational trial. As such, the trial data will dictate the steps for Seelos.
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By GlobalDataThe CEO noted that there is a possibility but no guarantee that the FDA may consider approval based on the single study. For this to happen, the data needs to show a high statistical significance and 99% confidence interval, which requires a P value of less than 0.01.
Recruiting suicidal patient population
Seelos closed enrolment for the second part of the Phase II trial in June. The company dosed its first patient for this portion of the trial in July 2021. While facing enrolment challenges due to the Covid-19 pandemic, the patient population is also inherently difficult to recruit.
Mehra said: “The patient population is extremely vulnerable and almost everybody avoids them because you don’t want to conduct a study where patients are determined to kill themselves.”
The biggest fear for Seelos was administering a placebo to participants, especially when they were in the outpatient setting, as they were most vulnerable. The study design included one week of treatment in a hospital, followed by one week in the outpatient setting, which is similar to how these patients are treated in real life in the US.
The CEO added: “So far, we have the last patients coming out from the study in the next week or so, and we have kept them all alive. That in itself will be a huge accomplishment.”
